A Study of BBI608 in Adult Patients With Advanced Colorectal Cancer
Sponsor
Sumitomo Pharma Oncology, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01776307
Collaborator
(none)
200
13
3
97
15.4
0.2
Study Details
Study Description
Brief Summary
This is an open label, multi-center, Phase 2 study of BBI608 in combination with cetuximab, panitumumab or capecitabine in patients with advanced colorectal cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
This is an open label, multi-center, Phase 2 study of BBI608 administered in combination with either cetuximab, or panitumumab, or capecitabine. A cycle will consist of daily and continuous oral administration of BBI608 for four weeks in combination with either cetuximab, or panitumumab, or capecitabine.
Study Design
Study Type:
Interventional
Actual Enrollment
:
200 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Clinical Study of BBI608 in Adult Patients With Advanced Colorectal Cancer
Study Start Date
:
Mar 1, 2012
Actual Primary Completion Date
:
Jun 1, 2018
Actual Study Completion Date
:
Apr 1, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: BBI608 in combination with cetuximab
|
Drug: BBI608
BBI608 is administered at 500 mg po bid continuously.
Other Names:
Drug: Cetuximab
Cetuximab will be administered IV on day 5 at 400 mg/m2 intravenous infusion over 120 minutes as the initial dose, then weekly at 250mg/m2 over 60-minutes at subsequent cycles.
Other Names:
|
| Experimental: BBI608 in combination with panitumumab
|
Drug: BBI608
BBI608 is administered at 500 mg po bid continuously.
Other Names:
Drug: Panitumumab
Panitumumab will be administered IV on day 8 and 22 of each 28 day cycle at 6 mg/kg over 60 minutes.
Other Names:
|
| Experimental: BBI608 in combination with capecitabine
|
Drug: BBI608
BBI608 is administered at 500 mg po bid continuously.
Other Names:
Drug: Capecitabine
Capecitabine will be administered orally at 1000 mg/m2 bid daily on days 8-21 every three weeks.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Disease Control Rate [From the date of first treatment, every 8 weeks, until the date of first documented objective disease progression, up to 24 months]
Assessment of Disease Control Rate, defined as the proportion of patients with a documented complete response, partial response and stable disease based on RECIST 1.1, in patients with advanced colorectal cancer given napabucasin in combination with cetuximab, panitumumab or capecitabine
Secondary Outcome Measures
- Progression Free Survival [The time from the date of first treatment to the date of first documentation of disease progression or death due to any cause, up to 24 months]
The effect of napabucasin given in combination with cetuximab, panitumumab or capecitabine on Progression Free Survival (PFS) of patients with advanced colorectal cancer.
- Overall Survival [4 weeks after the patient has been off study treatment, every 3 months thereafter until death, up to 60 months.]
The effect of napabucasin given in combination with cetuximab, panitumumab or capecitabine on the Overall Survival of patients with advanced colorectal cancer
- Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 480mg, Twice Daily, on Day 5 of the First Study Cycle [Blood samples drawn on day 5 during the first study cycle]
To determine the maximum concentration of napabucasin when given at 480mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer.
- Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 480mg, Twice Daily, on Day 21 of the First Study Cycle [Blood samples drawn on day 21 during the first study cycle]
To determine the maximum concentration of napabucasin when given at 480mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer.
- Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 240mg, Twice Daily, on Day 21 of the First Study Cycle [Blood samples drawn on day 21 during the first study cycle]
To determine the maximum concentration of napabucasin when given at 240mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer.
- Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 500mg, Twice Daily, on Day 5 of the First Study Cycle [Blood samples drawn on day 5 during the first study cycle]
To determine the maximum concentration of napabucasin when given at 500mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer.
- Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 500mg, Twice Daily, on Day 21 of the First Study Cycle [Blood samples drawn on day 21 during the first study cycle]
To determine the maximum concentration of napabucasin when given at 500mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer.
- Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 480mg, Twice Daily, on Day 5 of the First Study Cycle [Blood samples drawn on day 5 during the first study cycle]
To determine the area under the plasma concentration vs. time curve of napabucasin when given at 480mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer.
- Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 480mg, Twice Daily, on Day 21 of the First Study Cycle [Blood samples drawn on day 21 during the first study cycle]
To determine the area under the plasma concentration vs. time curve of napabucasin when given at 480mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer.
- Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 240mg, Twice Daily, on Day 21 of the First Study Cycle [Blood samples drawn on day 21 during the first study cycle]
To determine the area under the plasma concentration vs. time curve of napabucasin when given at 240mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer.
- Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 500mg, Twice Daily, on Day 5 of the First Study Cycle [Blood samples drawn on day 5 during the first study cycle]
To determine the area under the plasma concentration vs. time curve of napabucasin when given at 500mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer.
- Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 500mg, Twice Daily, on Day 21 of the First Study Cycle [Blood samples drawn on day 21 during the first study cycle]
To determine the area under the plasma concentration vs. time curve of napabucasin when given at 500mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer.
- Pharmacodynamics [During the first 28 days of the study cycle]
To determine the response (increase or decrease) of biomarkers from biopsied tumors following the administration of napabucasin
- Number of Patients With Adverse Events and Serious Adverse Events [The time from the date of first treatment, while the patient is taking napabucasin, and for 30 days after stopping therapy, an average of 4 months.]
Assessment of safety of napabucasin given in combination with cetuximab, panitumumab or capecitabine to patients with advanced colorectal cancer by reporting of adverse events and serious adverse events
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Signed written informed consent must be obtained and documented according to International Conference on Harmonization (ICH), Good Clinical Practice(GCP), the local regulatory requirements, and permission to use private health information in accordance with the Health Insurance Portability and Accountability Act (HIPPA) prior to study-specific screening procedures.
-
A histologically or cytologically confirmed colorectal cancer that is metastatic, unresectable, or recurrent.
-
Patients must have received at least 2 regimens containing 5-Fluorouracil,oxaliplatin, or irinotecan.
-
Patients to be enrolled in the Cetuximab or Panitumumab combination arms must have colorectal cancer which is K-Ras wild-type.
-
≥ 18 years of age.
-
Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
-
Karnofsky performance Status ≥ 70%
-
Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last BBI608 dose.
-
Females of childbearing potential must have a negative serum pregnancy test.
-
Aspartate transaminase (AST) and alanine transaminase (ALT) ≤1.5 × upper limit of normal(ULN), or ≤ 2.5 × ULN with metastatic liver disease.
-
Hemoglobin (Hgb) ≥ 10 g/dl.
-
Total bilirubin ≤ 1.5 × ULN.
-
Creatinine ≤ 1.5 × ULN or creatinine clearance > 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal.
-
Absolute neutrophil count ≥ 1.5 x 10^9/L.
-
Platelets ≥ 100 x 10^9/L.
-
Life expectancy ≥ 3 months.
Exclusion Criteria:
-
Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within four weeks of first dose with the exception for a single dose radiation up to 8 Gray (equal to 800 RAD) with palliative intent for pain control up to 14 days before beginning the administration of BBI608.
-
Surgery within 4 weeks prior to first dose.
-
Any known symptomatic brain metastases requiring steroids. Patients with treated brain metastases must be stable for 4 weeks after completion of that treatment, with image documentation required. Patients must have no clinical symptoms from brain metastases and must be either off steroids or on a stable dose of steroids for at least 2 weeks prior to protocol enrollment. Patients with known leptomeningeal metastases are excluded, even if treated.
-
Pregnant or breastfeeding
-
Significant gastrointestinal disorder(s), in the opinion of the Principal Investigator, (e.g., Crohn's disease, ulcerative colitis, extensive gastric and small intestine resection)
-
Unable or unwilling to swallow BBI608 capsules daily.
-
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, clinically significant non-healing or healing wounds, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic | Scottsdale | Arizona | United States | 85259 |
| 2 | USOR - Rocky Mountain Cancer Center | Denver | Colorado | United States | 80218 |
| 3 | Mayo Clinic | Jacksonville | Florida | United States | 32224 |
| 4 | USOR - Minnesota Oncology Hematology | Minneapolis | Minnesota | United States | 55404 |
| 5 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
| 6 | The Ohio State University Comprehensive Cancer Center | Columbus | Ohio | United States | 43210 |
| 7 | USOR - Northwest Cancer Specialists | Portland | Oregon | United States | 97227 |
| 8 | Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
| 9 | Institute for Translational Oncology Research, Greenville Hospital System | Greenville | South Carolina | United States | 29605 |
| 10 | USOR - Texas Oncology Dallas | Dallas | Texas | United States | 75246 |
| 11 | US Oncology Research | The Woodlands | Texas | United States | 77380 |
| 12 | USOR - Texas Oncology Tyler | Tyler | Texas | United States | 75702 |
| 13 | USOR - Virginia Cancer Specialists | Fairfax | Virginia | United States | 22031 |
Sponsors and Collaborators
- Sumitomo Pharma Oncology, Inc.
Investigators
- Principal Investigator: William J. Edenfield, MD, Institute for Translational Oncology Research, Greenville Hospital System
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Sumitomo Pharma Oncology, Inc.
ClinicalTrials.gov Identifier:
NCT01776307
Other Study ID Numbers:
- BBI608-224
First Posted:
Jan 28, 2013
Last Update Posted:
Apr 6, 2022
Last Verified:
Apr 1, 2022
Keywords provided by Sumitomo Pharma Oncology, Inc.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | 200 participants were enrolled between March 2012 and July 2017. |
|---|---|
| Pre-assignment Detail | Patients who died, withdrew consent to survival follow up or were lost to follow up were considered to have completed the study. |
| Arm/Group Title | Napabucasin Plus Cetuximab | Napabucasin Plus Panitumumab | Napabucasin Plus Capecitabine |
|---|---|---|---|
| Arm/Group Description | All participants who were enrolled to Arm A to receive napabucasin administered orally, twice daily in combination with weekly cetuximab administered intravenously | All participants who were enrolled to Arm B to receive napabucasin administered orally, twice daily in combination with panitumumab administered intravenously on day 8 and 22 of each 28 day cycle | All participants who were enrolled to Arm C to receive napabucasin administered orally, twice daily in combination with capecitabine administered twice daily on days 8-21 every three weeks |
| Period Title: Overall Study | |||
| STARTED | 49 | 75 | 76 |
| COMPLETED | 49 | 75 | 75 |
| NOT COMPLETED | 0 | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | Napabucasin Plus Cetuximab | Napabucasin Plus Panitumumab | Napabucasin Plus Capecitabine | Total |
|---|---|---|---|---|
| Arm/Group Description | All participants who were enrolled to Arm A to receive napabucasin administered orally, twice daily in combination with weekly cetuximab administered intravenously | All participants who were enrolled to Arm B to receive napabucasin administered orally, twice daily in combination with panitumumab administered intravenously on day 8 and 22 of each 28 day cycle | All participants who were enrolled to Arm C to receive napabucasin administered orally, twice daily in combination with capecitabine administered twice daily on days 8-21 every three weeks | Total of all reporting groups |
| Overall Participants | 49 | 75 | 75 | 199 |
| Age, Customized (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
56.3
(10.37)
|
59.7
(11.94)
|
58.1
(11.20)
|
58.3
(11.31)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
27
55.1%
|
35
46.7%
|
24
32%
|
86
43.2%
|
| Male |
22
44.9%
|
40
53.3%
|
51
68%
|
113
56.8%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
3
6.1%
|
0
0%
|
3
4%
|
6
3%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
2
4.1%
|
4
5.3%
|
8
10.7%
|
14
7%
|
| White |
39
79.6%
|
69
92%
|
64
85.3%
|
172
86.4%
|
| More than one race |
3
6.1%
|
2
2.7%
|
0
0%
|
5
2.5%
|
| Unknown or Not Reported |
2
4.1%
|
0
0%
|
0
0%
|
2
1%
|
Outcome Measures
| Title | Disease Control Rate |
|---|---|
| Description | Assessment of Disease Control Rate, defined as the proportion of patients with a documented complete response, partial response and stable disease based on RECIST 1.1, in patients with advanced colorectal cancer given napabucasin in combination with cetuximab, panitumumab or capecitabine |
| Time Frame | From the date of first treatment, every 8 weeks, until the date of first documented objective disease progression, up to 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Patients who received at least 1 cycle of study treatment and had at least 1 disease assessment following the initiation of therapy. Patients missing imaging assessment following the initiation of treatment are not included in the assessment for DCR. |
| Arm/Group Title | Napabucasin Plus Cetuximab | Napabucasin Plus Panitumumab | Napabucasin Plus Capecitabine |
|---|---|---|---|
| Arm/Group Description | Napabucasin administered orally, twice daily, in combination with weekly cetuximab administered intravenously on Days 5, 12, 19, and 26 of each 28 day study cycle. Patients in this group had a baseline scan and at least one assessment approximately 8 weeks from baseline. | Napabucasin administered orally, twice daily, in combination with panitumumab administered intravenously on Days 8 and 22 of each 28 day study cycle. Patients in this group had a baseline scan and at least one assessment approximately 8 weeks from baseline. | Napabucasin administered orally, twice daily, in combination with capecitabine administered twice daily on Days 8-21 every three weeks. Patients in this group had a baseline scan and at least one assessment approximately 8 weeks from baseline. |
| Measure Participants | 29 | 41 | 39 |
| Number (95% Confidence Interval) [Percentage of participants] |
34.5
70.4%
|
36.6
48.8%
|
25.6
34.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Napabucasin Plus Cetuximab, Napabucasin Plus Panitumumab, Napabucasin Plus Capecitabine |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | Descriptive analysis for investigational arms; no comparator analysis | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Other Statistical Analysis | The exact 95% confidence interval is based on the Clopper-Pearson method. | |
| Title | Progression Free Survival |
|---|---|
| Description | The effect of napabucasin given in combination with cetuximab, panitumumab or capecitabine on Progression Free Survival (PFS) of patients with advanced colorectal cancer. |
| Time Frame | The time from the date of first treatment to the date of first documentation of disease progression or death due to any cause, up to 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Napabucasin Plus Cetuximab | Napabucasin Plus Panitumumab | Napabucasin Plus Capecitabine |
|---|---|---|---|
| Arm/Group Description | Napabucasin administered orally, twice daily, in combination with weekly cetuximab administered intravenously on Days 5, 12, 19, and 26 of each 28 day study cycle . Patients in this group had a baseline scan and at least one on study scan or died from any cause. | Napabucasin administered orally, twice daily, in combination with panitumumab administered intravenously on Days 8 and 22 of each 28 day study cycle. Patients in this group had a baseline scan and at least one on study scan or died from any cause. | Napabucasin administered orally, twice daily, in combination with capecitabine administered twice daily on Days 8-21 every three weeks. Patients in this group had a baseline scan and at least one on study scan or died from any cause |
| Measure Participants | 49 | 75 | 75 |
| Median (95% Confidence Interval) [months] |
1.87
|
2.27
|
1.94
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Napabucasin Plus Cetuximab, Napabucasin Plus Panitumumab, Napabucasin Plus Capecitabine |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | Estimates provided for investigational arms; no comparator analysis | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Other Statistical Analysis | Estimated from Kaplan Meier Curve | |
| Title | Overall Survival |
|---|---|
| Description | The effect of napabucasin given in combination with cetuximab, panitumumab or capecitabine on the Overall Survival of patients with advanced colorectal cancer |
| Time Frame | 4 weeks after the patient has been off study treatment, every 3 months thereafter until death, up to 60 months. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Napabucasin Plus Cetuximab | Napabucasin Plus Panitumumab | Napabucasin Plus Capecitabine |
|---|---|---|---|
| Arm/Group Description | Napabucasin administered orally, twice daily, in combination with weekly cetuximab administered intravenously on Days 5, 12, 19, and 26 of each 28 day study cycle. | Napabucasin administered orally, twice daily, in combination with panitumumab administered intravenously on Days 8 and 22 of each 28 day study cycle. | Napabucasin administered orally, twice daily, in combination with capecitabine administered twice daily on Days 8-21 every three weeks. |
| Measure Participants | 49 | 75 | 75 |
| Median (95% Confidence Interval) [Months] |
7.79
|
9.10
|
6.34
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Napabucasin Plus Cetuximab, Napabucasin Plus Panitumumab, Napabucasin Plus Capecitabine |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | Estimates provided for investigational arms; no comparator analysis | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Other Statistical Analysis | Estimated from Kaplan Meier Curve | |
| Title | Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 480mg, Twice Daily, on Day 5 of the First Study Cycle |
|---|---|
| Description | To determine the maximum concentration of napabucasin when given at 480mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer. |
| Time Frame | Blood samples drawn on day 5 during the first study cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| Napabucasin plus capecitabine: No evaluable patients dosed at 480mg twice daily. |
| Arm/Group Title | Napabucasin Plus Cetuximab | Napabucasin Plus Panitumumab | Napabucasin Plus Capecitabine |
|---|---|---|---|
| Arm/Group Description | Napabucasin administered orally, twice daily, in combination with weekly cetuximab administered intravenously on Days 5, 12, 19, and 26 of each 28 day study cycle. Patients included in this group took napabucasin 480mg twice daily and provided blood samples for analysis. | Napabucasin administered orally, twice daily, in combination with panitumumab administered intravenously on Days 8 and 22 of each 28 day study cycle. Patients included in this group took napabucasin 480mg twice daily and provided blood samples for analysis. | Napabucasin administered orally, twice daily, in combination with capecitabine administered twice daily on Days 8-21 every three weeks. Patients included in this group took napabucasin 480mg twice daily and provided blood samples for analysis. |
| Measure Participants | 6 | 1 | 0 |
| Geometric Mean (Geometric Coefficient of Variation) [ng/mL] |
661
(77.9)
|
468
(NA)
|
| Title | Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 480mg, Twice Daily, on Day 21 of the First Study Cycle |
|---|---|
| Description | To determine the maximum concentration of napabucasin when given at 480mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer. |
| Time Frame | Blood samples drawn on day 21 during the first study cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| Napabucasin plus capecitabine: No evaluable patients dosed at 480mg twice daily. |
| Arm/Group Title | Napabucasin Plus Cetuximab | Napabucasin Plus Panitumumab | Napabucasin Plus Capecitabine |
|---|---|---|---|
| Arm/Group Description | Napabucasin administered orally, twice daily, in combination with weekly cetuximab administered intravenously on Days 5, 12, 19, and 26 of each 28 day study cycle. Patients included in this group took napabucasin 480mg twice daily and provided blood samples for analysis. | Napabucasin administered orally, twice daily, in combination with panitumumab administered intravenously on Days 8 and 22 of each 28 day study cycle. Patients included in this group took napabucasin 480mg twice daily and provided blood samples for analysis. | Napabucasin administered orally, twice daily, in combination with capecitabine administered twice daily on Days 8-21 every three weeks. Patients included in this group took napabucasin 480mg twice daily and provided blood samples for analysis. |
| Measure Participants | 5 | 1 | 0 |
| Geometric Mean (Geometric Coefficient of Variation) [ng/mL] |
627
(77.3)
|
398
(NA)
|
| Title | Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 240mg, Twice Daily, on Day 21 of the First Study Cycle |
|---|---|
| Description | To determine the maximum concentration of napabucasin when given at 240mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer. |
| Time Frame | Blood samples drawn on day 21 during the first study cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| Napabucasin plus panitumumab & Napabucasin plus capecitabine: No evaluable patients dosed at 240mg twice daily. |
| Arm/Group Title | Napabucasin Plus Cetuximab | Napabucasin Plus Panitumumab | Napabucasin Plus Capecitabine |
|---|---|---|---|
| Arm/Group Description | Napabucasin administered orally, twice daily, in combination with weekly cetuximab administered intravenously on Days 5, 12, 19, and 26 of each 28 day study cycle. Patients included in this group took napabucasin 240mg twice daily and provided blood samples for analysis. | Napabucasin administered orally, twice daily, in combination with panitumumab administered intravenously on Days 8 and 22 of each 28 day study cycle. Patients included in this group took napabucasin 240mg twice daily and provided blood samples for analysis. | Napabucasin administered orally, twice daily, in combination with capecitabine administered twice daily on Days 8-21 every three weeks. Patients included in this group took napabucasin 240mg twice daily and provided blood samples for analysis. |
| Measure Participants | 1 | 0 | 0 |
| Geometric Mean (Geometric Coefficient of Variation) [ng/mL] |
494
(NA)
|
| Title | Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 500mg, Twice Daily, on Day 5 of the First Study Cycle |
|---|---|
| Description | To determine the maximum concentration of napabucasin when given at 500mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer. |
| Time Frame | Blood samples drawn on day 5 during the first study cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| Napabucasin plus cetuximab: No evaluable patients dosed at 500mg twice daily. |
| Arm/Group Title | Napabucasin Plus Cetuximab | Napabucasin Plus Panitumumab | Napabucasin Plus Capecitabine |
|---|---|---|---|
| Arm/Group Description | Napabucasin administered orally, twice daily, in combination with weekly cetuximab administered intravenously on Days 5, 12, 19, and 26 of each 28 day study cycle. Patients included in this group took napabucasin 500mg twice daily and provided blood samples for analysis. | Napabucasin administered orally, twice daily, in combination with panitumumab administered intravenously on Days 8 and 22 of each 28 day study cycle. Patients included in this group took napabucasin 500mg twice daily and provided blood samples for analysis. | Napabucasin administered orally, twice daily, in combination with capecitabine administered twice daily on Days 8-21 every three weeks. Patients included in this group took napabucasin 500mg twice daily and provided blood samples for analysis. |
| Measure Participants | 0 | 4 | 6 |
| Geometric Mean (Geometric Coefficient of Variation) [ng/mL] |
1020
(50.6)
|
858
(34.5)
|
| Title | Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 500mg, Twice Daily, on Day 21 of the First Study Cycle |
|---|---|
| Description | To determine the maximum concentration of napabucasin when given at 500mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer. |
| Time Frame | Blood samples drawn on day 21 during the first study cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| Napabucasin plus cetuximab: No evaluable patients dosed at 500mg twice daily. |
| Arm/Group Title | Napabucasin Plus Cetuximab | Napabucasin Plus Panitumumab | Napabucasin Plus Capecitabine |
|---|---|---|---|
| Arm/Group Description | Napabucasin administered orally, twice daily, in combination with weekly cetuximab administered intravenously on Days 5, 12, 19, and 26 of each 28 day study cycle. Patients included in this group took napabucasin 500mg twice daily and provided blood samples for analysis. | Napabucasin administered orally, twice daily, in combination with panitumumab administered intravenously on Days 8 and 22 of each 28 day study cycle. Patients included in this group took napabucasin 500mg twice daily and provided blood samples for analysis. | Napabucasin administered orally, twice daily, in combination with capecitabine administered twice daily on Days 8-21 every three weeks. Patients included in this group took napabucasin 500mg twice daily and provided blood samples for analysis. |
| Measure Participants | 0 | 3 | 5 |
| Geometric Mean (Geometric Coefficient of Variation) [ng/mL] |
1060
(23.0)
|
789
(72.0)
|
| Title | Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 480mg, Twice Daily, on Day 5 of the First Study Cycle |
|---|---|
| Description | To determine the area under the plasma concentration vs. time curve of napabucasin when given at 480mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer. |
| Time Frame | Blood samples drawn on day 5 during the first study cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| Napabucasin plus capecitabine: No evaluable patients dosed at 480mg twice daily. |
| Arm/Group Title | Napabucasin Plus Cetuximab | Napabucasin Plus Panitumumab | Napabucasin Plus Capecitabine |
|---|---|---|---|
| Arm/Group Description | Napabucasin administered orally, twice daily, in combination with weekly cetuximab administered intravenously on Days 5, 12, 19, and 26 of each 28 day study cycle. Patients included in this group took napabucasin 480mg twice daily and provided blood samples for analysis. | Napabucasin administered orally, twice daily, in combination with panitumumab administered intravenously on Days 8 and 22 of each 28 day study cycle. Patients included in this group took napabucasin 480mg twice daily and provided blood samples for analysis. | Napabucasin administered orally, twice daily, in combination with capecitabine administered twice daily on Days 8-21 every three weeks. Patients included in this group took napabucasin 480mg twice daily and provided blood samples for analysis. |
| Measure Participants | 6 | 1 | 0 |
| Geometric Mean (Geometric Coefficient of Variation) [h*ng/mL] |
3380
(83.3)
|
2730
(NA)
|
| Title | Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 480mg, Twice Daily, on Day 21 of the First Study Cycle |
|---|---|
| Description | To determine the area under the plasma concentration vs. time curve of napabucasin when given at 480mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer. |
| Time Frame | Blood samples drawn on day 21 during the first study cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| Napabucasin plus capecitabine: No evaluable patients dosed at 480mg twice daily. |
| Arm/Group Title | Napabucasin Plus Cetuximab | Napabucasin Plus Panitumumab | Napabucasin Plus Capecitabine |
|---|---|---|---|
| Arm/Group Description | Napabucasin administered orally, twice daily, in combination with weekly cetuximab administered intravenously on Days 5, 12, 19, and 26 of each 28 day study cycle. Patients included in this group took napabucasin 480mg twice daily and provided blood samples for analysis. | Napabucasin administered orally, twice daily, in combination with panitumumab administered intravenously on Days 8 and 22 of each 28 day study cycle. Patients included in this group took napabucasin 480mg twice daily and provided blood samples for analysis. | Napabucasin administered orally, twice daily, in combination with capecitabine administered twice daily on Days 8-21 every three weeks. Patients included in this group took napabucasin 480mg twice daily and provided blood samples for analysis. |
| Measure Participants | 5 | 1 | 0 |
| Geometric Mean (Geometric Coefficient of Variation) [h*ng/mL] |
2930
(137)
|
2630
(NA)
|
| Title | Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 240mg, Twice Daily, on Day 21 of the First Study Cycle |
|---|---|
| Description | To determine the area under the plasma concentration vs. time curve of napabucasin when given at 240mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer. |
| Time Frame | Blood samples drawn on day 21 during the first study cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| Napabucasin plus panitumumab and Napabucasin plus capecitabine: No evaluable patients dosed at 240mg twice daily. |
| Arm/Group Title | Napabucasin Plus Cetuximab | Napabucasin Plus Panitumumab | Napabucasin Plus Capecitabine |
|---|---|---|---|
| Arm/Group Description | Napabucasin administered orally, twice daily, in combination with weekly cetuximab administered intravenously on Days 5, 12, 19, and 26 of each 28 day study cycle. Patients included in this group took napabucasin 240mg twice daily and provided blood samples for analysis. | Napabucasin administered orally, twice daily, in combination with panitumumab administered intravenously on Days 8 and 22 of each 28 day study cycle. Patients included in this group took napabucasin 240mg twice daily and provided blood samples for analysis. | Napabucasin administered orally, twice daily, in combination with capecitabine administered twice daily on Days 8-21 every three weeks. Patients included in this group took napabucasin 240mg twice daily and provided blood samples for analysis. |
| Measure Participants | 1 | 0 | 0 |
| Geometric Mean (Geometric Coefficient of Variation) [h*ng/mL] |
2870
(NA)
|
| Title | Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 500mg, Twice Daily, on Day 5 of the First Study Cycle |
|---|---|
| Description | To determine the area under the plasma concentration vs. time curve of napabucasin when given at 500mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer. |
| Time Frame | Blood samples drawn on day 5 during the first study cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| Napabucasin plus cetuximab: No evaluable patients dosed at 500mg twice daily. |
| Arm/Group Title | Napabucasin Plus Cetuximab | Napabucasin Plus Panitumumab | Napabucasin Plus Capecitabine |
|---|---|---|---|
| Arm/Group Description | Napabucasin administered orally, twice daily, in combination with weekly cetuximab administered intravenously on Days 5, 12, 19, and 26 of each 28 day study cycle. Patients included in this group took napabucasin 500mg twice daily and provided blood samples for analysis. | Napabucasin administered orally, twice daily, in combination with panitumumab administered intravenously on Days 8 and 22 of each 28 day study cycle. Patients included in this group took napabucasin 500mg twice daily and provided blood samples for analysis. | Napabucasin administered orally, twice daily, in combination with capecitabine administered twice daily on Days 8-21 every three weeks. Patients included in this group took napabucasin 500mg twice daily and provided blood samples for analysis. |
| Measure Participants | 0 | 4 | 6 |
| Geometric Mean (Geometric Coefficient of Variation) [h*ng/mL] |
5420
(36.3)
|
5350
(38.7)
|
| Title | Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 500mg, Twice Daily, on Day 21 of the First Study Cycle |
|---|---|
| Description | To determine the area under the plasma concentration vs. time curve of napabucasin when given at 500mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer. |
| Time Frame | Blood samples drawn on day 21 during the first study cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| Napabucasin plus cetuximab: No evaluable patients dosed at 500mg twice daily. |
| Arm/Group Title | Napabucasin Plus Cetuximab | Napabucasin Plus Panitumumab | Napabucasin Plus Capecitabine |
|---|---|---|---|
| Arm/Group Description | Napabucasin administered orally, twice daily, in combination with weekly cetuximab administered intravenously on Days 5, 12, 19, and 26 of each 28 day study cycle. Patients included in this group took napabucasin 500mg twice daily and provided blood samples for analysis. | Napabucasin administered orally, twice daily, in combination with panitumumab administered intravenously on Days 8 and 22 of each 28 day study cycle. Patients included in this group took napabucasin 500mg twice daily and provided blood samples for analysis. | Napabucasin administered orally, twice daily, in combination with capecitabine administered twice daily on Days 8-21 every three weeks. Patients included in this group took napabucasin 500mg twice daily and provided blood samples for analysis. |
| Measure Participants | 0 | 3 | 5 |
| Geometric Mean (Geometric Coefficient of Variation) [h*ng/mL] |
6290
(6.71)
|
4720
(48.2)
|
| Title | Pharmacodynamics |
|---|---|
| Description | To determine the response (increase or decrease) of biomarkers from biopsied tumors following the administration of napabucasin |
| Time Frame | During the first 28 days of the study cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| No on-treatment biopsies were performed therefore no pharmacodynamic testing on tumor tissue was conducted. |
| Arm/Group Title | Napabucasin Plus Cetuximab | Napabucasin Plus Panitumumab | Napabucasin Plus Capecitabine |
|---|---|---|---|
| Arm/Group Description | Napabucasin administered orally, twice daily, in combination with weekly cetuximab administered intravenously on Days 5, 12, 19, and 26 of each 28 day study cycle . Patients included in this group needed to have on treatment biopsy | Napabucasin administered orally, twice daily, in combination with panitumumab administered intravenously on Days 8 and 22 of each 28 day study cycle. Patients included in this group needed to have on treatment biopsy | Napabucasin administered orally, twice daily, in combination with capecitabine administered twice daily on Days 8-21 every three weeks. Patients included in this group needed to have on treatment biopsy. |
| Measure Participants | 0 | 0 | 0 |
| Title | Number of Patients With Adverse Events and Serious Adverse Events |
|---|---|
| Description | Assessment of safety of napabucasin given in combination with cetuximab, panitumumab or capecitabine to patients with advanced colorectal cancer by reporting of adverse events and serious adverse events |
| Time Frame | The time from the date of first treatment, while the patient is taking napabucasin, and for 30 days after stopping therapy, an average of 4 months. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Napabucasin Plus Cetuximab | Napabucasin Plus Panitumumab | Napabucasin Plus Capecitabine |
|---|---|---|---|
| Arm/Group Description | Napabucasin administered orally, twice daily, in combination with weekly cetuximab administered intravenously on Days 5, 12, 19, and 26 of each 28 day study cycle. Patients included in this group received at least one dose of study drug. | Napabucasin administered orally, twice daily, in combination with panitumumab administered intravenously on Days 8 and 22 of each 28 day study cycle. Patients included in this group received at least one dose of study drug. | Napabucasin administered orally, twice daily, in combination with capecitabine administered twice daily on Days 8-21 every three weeks. Patients included in this group received at least one dose of study drug. |
| Measure Participants | 49 | 75 | 75 |
| Count of Participants [Participants] |
49
100%
|
75
100%
|
75
100%
|
Adverse Events
| Time Frame | Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, assessed up to 60 months. | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Napabucasin Plus Cetuximab | Napabucasin Plus Panitumumab | Napabucasin Plus Capecitabine | |||
| Arm/Group Description | All participants who received at least 1 dose of napabucasin administered orally, twice daily in combination with weekly cetuximab administered intravenously | All participants who received at least 1 dose of napabucasin administered orally, twice daily in combination with panitumumab administered intravenously on day 8 and 22 of each 28 day cycle | All participants who received at least 1 dose of napabucasin administered orally, twice daily in combination with capecitabine administered twice daily on days 8-21 every three weeks | |||
All Cause Mortality |
||||||
| Napabucasin Plus Cetuximab | Napabucasin Plus Panitumumab | Napabucasin Plus Capecitabine | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 45/49 (91.8%) | 70/75 (93.3%) | 72/75 (96%) | |||
Serious Adverse Events |
||||||
| Napabucasin Plus Cetuximab | Napabucasin Plus Panitumumab | Napabucasin Plus Capecitabine | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 17/49 (34.7%) | 29/75 (38.7%) | 26/75 (34.7%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 0/49 (0%) | 1/75 (1.3%) | 0/75 (0%) | |||
| Cardiac disorders | ||||||
| Atrial fibrillation | 0/49 (0%) | 1/75 (1.3%) | 0/75 (0%) | |||
| Pericardial effusion | 0/49 (0%) | 1/75 (1.3%) | 0/75 (0%) | |||
| Gastrointestinal disorders | ||||||
| Abdominal pain | 4/49 (8.2%) | 4/75 (5.3%) | 5/75 (6.7%) | |||
| Diarrhoea | 4/49 (8.2%) | 0/75 (0%) | 2/75 (2.7%) | |||
| Nausea | 2/49 (4.1%) | 1/75 (1.3%) | 0/75 (0%) | |||
| Constipation | 1/49 (2%) | 0/75 (0%) | 1/75 (1.3%) | |||
| Gastrointestinal haemorrhage | 1/49 (2%) | 2/75 (2.7%) | 1/75 (1.3%) | |||
| Large intestine perforation | 1/49 (2%) | 0/75 (0%) | 0/75 (0%) | |||
| Small intestinal obstruction | 1/49 (2%) | 3/75 (4%) | 2/75 (2.7%) | |||
| Vomiting | 1/49 (2%) | 2/75 (2.7%) | 2/75 (2.7%) | |||
| Ascites | 0/49 (0%) | 1/75 (1.3%) | 0/75 (0%) | |||
| Colitis | 0/49 (0%) | 1/75 (1.3%) | 0/75 (0%) | |||
| Intestinal obstruction | 0/49 (0%) | 1/75 (1.3%) | 1/75 (1.3%) | |||
| Pancreatitis acute | 0/49 (0%) | 0/75 (0%) | 1/75 (1.3%) | |||
| General disorders | ||||||
| Disease progression | 3/49 (6.1%) | 3/75 (4%) | 0/75 (0%) | |||
| Pyrexia | 0/49 (0%) | 3/75 (4%) | 0/75 (0%) | |||
| Chest pain | 0/49 (0%) | 1/75 (1.3%) | 0/75 (0%) | |||
| Device dislocation | 0/49 (0%) | 1/75 (1.3%) | 0/75 (0%) | |||
| Oedema peripheral | 0/49 (0%) | 1/75 (1.3%) | 0/75 (0%) | |||
| Asthenia | 0/49 (0%) | 0/75 (0%) | 1/75 (1.3%) | |||
| Pain | 0/49 (0%) | 0/75 (0%) | 1/75 (1.3%) | |||
| Hepatobiliary disorders | ||||||
| Bile duct obstruction | 1/49 (2%) | 0/75 (0%) | 3/75 (4%) | |||
| Hepatic failure | 1/49 (2%) | 0/75 (0%) | 0/75 (0%) | |||
| Cholangitis | 0/49 (0%) | 1/75 (1.3%) | 1/75 (1.3%) | |||
| Hyperbilirubinaemia | 0/49 (0%) | 1/75 (1.3%) | 1/75 (1.3%) | |||
| Immune system disorders | ||||||
| Anaphylactic reaction | 1/49 (2%) | 0/75 (0%) | 0/75 (0%) | |||
| Infections and infestations | ||||||
| Sepsis | 1/49 (2%) | 2/75 (2.7%) | 1/75 (1.3%) | |||
| Clostridium difficile infection | 0/49 (0%) | 1/75 (1.3%) | 1/75 (1.3%) | |||
| Urinary tract infection | 0/49 (0%) | 1/75 (1.3%) | 0/75 (0%) | |||
| Pneumonia | 0/49 (0%) | 0/75 (0%) | 2/75 (2.7%) | |||
| Injury, poisoning and procedural complications | ||||||
| Renal haematoma | 0/49 (0%) | 1/75 (1.3%) | 0/75 (0%) | |||
| Investigations | ||||||
| Blood bilirubin increased | 0/49 (0%) | 1/75 (1.3%) | 0/75 (0%) | |||
| Blood creatinine increased | 0/49 (0%) | 1/75 (1.3%) | 0/75 (0%) | |||
| Metabolism and nutrition disorders | ||||||
| Dehydration | 1/49 (2%) | 3/75 (4%) | 2/75 (2.7%) | |||
| Hypoglycaemia | 0/49 (0%) | 1/75 (1.3%) | 0/75 (0%) | |||
| Hypomagnesaemia | 0/49 (0%) | 1/75 (1.3%) | 0/75 (0%) | |||
| Hypokalaemia | 0/49 (0%) | 0/75 (0%) | 1/75 (1.3%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Back pain | 0/49 (0%) | 1/75 (1.3%) | 0/75 (0%) | |||
| Flank pain | 0/49 (0%) | 1/75 (1.3%) | 0/75 (0%) | |||
| Pain in jaw | 0/49 (0%) | 1/75 (1.3%) | 0/75 (0%) | |||
| Bone pain | 0/49 (0%) | 0/75 (0%) | 1/75 (1.3%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Malignant neoplasm progression | 0/49 (0%) | 0/75 (0%) | 1/75 (1.3%) | |||
| Nervous system disorders | ||||||
| Haemorrhage intracranial | 0/49 (0%) | 1/75 (1.3%) | 0/75 (0%) | |||
| Hemiparesis | 0/49 (0%) | 0/75 (0%) | 1/75 (1.3%) | |||
| Hepatic encephalopathy | 0/49 (0%) | 0/75 (0%) | 1/75 (1.3%) | |||
| Renal and urinary disorders | ||||||
| Acute kidney injury | 0/49 (0%) | 2/75 (2.7%) | 3/75 (4%) | |||
| Haematuria | 0/49 (0%) | 1/75 (1.3%) | 0/75 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Dyspnoea | 2/49 (4.1%) | 1/75 (1.3%) | 1/75 (1.3%) | |||
| Acute respiratory failure | 1/49 (2%) | 0/75 (0%) | 0/75 (0%) | |||
| Pulmonary embolism | 1/49 (2%) | 2/75 (2.7%) | 0/75 (0%) | |||
| Pleural effusion | 0/49 (0%) | 0/75 (0%) | 3/75 (4%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Rash | 0/49 (0%) | 1/75 (1.3%) | 0/75 (0%) | |||
| Skin disorder | 0/49 (0%) | 1/75 (1.3%) | 0/75 (0%) | |||
| Vascular disorders | ||||||
| Hypotension | 0/49 (0%) | 0/75 (0%) | 1/75 (1.3%) | |||
| Thrombosis | 0/49 (0%) | 0/75 (0%) | 1/75 (1.3%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Napabucasin Plus Cetuximab | Napabucasin Plus Panitumumab | Napabucasin Plus Capecitabine | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 49/49 (100%) | 75/75 (100%) | 75/75 (100%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 9/49 (18.4%) | 16/75 (21.3%) | 16/75 (21.3%) | |||
| Lymphopenia | 1/49 (2%) | 9/75 (12%) | 18/75 (24%) | |||
| Thrombocytopenia | 1/49 (2%) | 6/75 (8%) | 5/75 (6.7%) | |||
| Leukopenia | 1/49 (2%) | 4/75 (5.3%) | 5/75 (6.7%) | |||
| Eye disorders | ||||||
| Vision blurred | 4/49 (8.2%) | 0/75 (0%) | 0/75 (0%) | |||
| Gastrointestinal disorders | ||||||
| Diarrhoea | 37/49 (75.5%) | 58/75 (77.3%) | 61/75 (81.3%) | |||
| Abdominal pain | 25/49 (51%) | 26/75 (34.7%) | 30/75 (40%) | |||
| Nausea | 22/49 (44.9%) | 39/75 (52%) | 47/75 (62.7%) | |||
| Vomiting | 22/49 (44.9%) | 27/75 (36%) | 27/75 (36%) | |||
| Constipation | 15/49 (30.6%) | 9/75 (12%) | 10/75 (13.3%) | |||
| Abdominal pain upper | 6/49 (12.2%) | 6/75 (8%) | 7/75 (9.3%) | |||
| Ascites | 2/49 (4.1%) | 5/75 (6.7%) | 3/75 (4%) | |||
| Abdominal distension | 3/49 (6.1%) | 3/75 (4%) | 6/75 (8%) | |||
| Stomatitis | 1/49 (2%) | 5/75 (6.7%) | 4/75 (5.3%) | |||
| General disorders | ||||||
| Fatigue | 20/49 (40.8%) | 43/75 (57.3%) | 36/75 (48%) | |||
| Oedema peripheral | 6/49 (12.2%) | 6/75 (8%) | 8/75 (10.7%) | |||
| Pyrexia | 6/49 (12.2%) | 5/75 (6.7%) | 7/75 (9.3%) | |||
| Mucosal inflammation | 5/49 (10.2%) | 3/75 (4%) | 3/75 (4%) | |||
| Chills | 3/49 (6.1%) | 6/75 (8%) | 3/75 (4%) | |||
| Disease progression | 3/49 (6.1%) | 3/75 (4%) | 0/75 (0%) | |||
| Asthenia | 0/49 (0%) | 5/75 (6.7%) | 7/75 (9.3%) | |||
| Hepatobiliary disorders | ||||||
| Hyperbilirubinaemia | 2/49 (4.1%) | 1/75 (1.3%) | 7/75 (9.3%) | |||
| Infections and infestations | ||||||
| Urinary tract infection | 4/49 (8.2%) | 15/75 (20%) | 6/75 (8%) | |||
| Injury, poisoning and procedural complications | ||||||
| Infusion related reaction | 3/49 (6.1%) | 1/75 (1.3%) | 0/75 (0%) | |||
| Investigations | ||||||
| Blood alkaline phosphatase increased | 7/49 (14.3%) | 9/75 (12%) | 12/75 (16%) | |||
| Aspartate aminotransferase increased | 6/49 (12.2%) | 6/75 (8%) | 13/75 (17.3%) | |||
| Blood bilirubin increased | 4/49 (8.2%) | 6/75 (8%) | 1/75 (1.3%) | |||
| Alanine aminotransferase increased | 4/49 (8.2%) | 5/75 (6.7%) | 5/75 (6.7%) | |||
| Blood lactate dehydrogenase increased | 4/49 (8.2%) | 1/75 (1.3%) | 0/75 (0%) | |||
| Blood creatinine increased | 3/49 (6.1%) | 1/75 (1.3%) | 5/75 (6.7%) | |||
| Weight decreased | 1/49 (2%) | 5/75 (6.7%) | 5/75 (6.7%) | |||
| Protein total decreased | 0/49 (0%) | 5/75 (6.7%) | 0/75 (0%) | |||
| Metabolism and nutrition disorders | ||||||
| Decreased appetite | 15/49 (30.6%) | 24/75 (32%) | 23/75 (30.7%) | |||
| Hypomagnesaemia | 15/49 (30.6%) | 23/75 (30.7%) | 4/75 (5.3%) | |||
| Hypokalaemia | 12/49 (24.5%) | 23/75 (30.7%) | 15/75 (20%) | |||
| Hypoalbuminaemia | 8/49 (16.3%) | 8/75 (10.7%) | 18/75 (24%) | |||
| Hypophosphataemia | 7/49 (14.3%) | 5/75 (6.7%) | 0/75 (0%) | |||
| Dehydration | 6/49 (12.2%) | 7/75 (9.3%) | 10/75 (13.3%) | |||
| Hyponatraemia | 5/49 (10.2%) | 2/75 (2.7%) | 12/75 (16%) | |||
| Hyperglycaemia | 4/49 (8.2%) | 15/75 (20%) | 22/75 (29.3%) | |||
| Hypocalcaemia | 2/49 (4.1%) | 5/75 (6.7%) | 2/75 (2.7%) | |||
| Hypouricaemia | 10/49 (20.4%) | 4/75 (5.3%) | 0/75 (0%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Back pain | 4/49 (8.2%) | 6/75 (8%) | 5/75 (6.7%) | |||
| Muscle spasms | 4/49 (8.2%) | 4/75 (5.3%) | 5/75 (6.7%) | |||
| Musculoskeletal pain | 4/49 (8.2%) | 1/75 (1.3%) | 2/75 (2.7%) | |||
| Muscular weakness | 3/49 (6.1%) | 2/75 (2.7%) | 2/75 (2.7%) | |||
| Pain in extremity | 3/49 (6.1%) | 1/75 (1.3%) | 3/75 (4%) | |||
| Arthralgia | 2/49 (4.1%) | 2/75 (2.7%) | 4/75 (5.3%) | |||
| Nervous system disorders | ||||||
| Dizziness | 7/49 (14.3%) | 7/75 (9.3%) | 9/75 (12%) | |||
| Headache | 5/49 (10.2%) | 6/75 (8%) | 3/75 (4%) | |||
| Psychiatric disorders | ||||||
| Insomnia | 4/49 (8.2%) | 3/75 (4%) | 3/75 (4%) | |||
| Anxiety | 3/49 (6.1%) | 3/75 (4%) | 3/75 (4%) | |||
| Depression | 1/49 (2%) | 5/75 (6.7%) | 4/75 (5.3%) | |||
| Renal and urinary disorders | ||||||
| Chromaturia | 11/49 (22.4%) | 12/75 (16%) | 10/75 (13.3%) | |||
| Proteinuria | 5/49 (10.2%) | 11/75 (14.7%) | 18/75 (24%) | |||
| Ketonuria | 3/49 (6.1%) | 11/75 (14.7%) | 17/75 (22.7%) | |||
| Haematuria | 2/49 (4.1%) | 9/75 (12%) | 10/75 (13.3%) | |||
| Glycosuria | 0/49 (0%) | 2/75 (2.7%) | 6/75 (8%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Dyspnoea | 7/49 (14.3%) | 13/75 (17.3%) | 13/75 (17.3%) | |||
| Cough | 2/49 (4.1%) | 9/75 (12%) | 10/75 (13.3%) | |||
| Pulmonary embolism | 2/49 (4.1%) | 4/75 (5.3%) | 0/75 (0%) | |||
| Pleural effusion | 0/49 (0%) | 1/75 (1.3%) | 5/75 (6.7%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Dermatitis acneiform | 10/49 (20.4%) | 13/75 (17.3%) | 0/75 (0%) | |||
| Dry skin | 10/49 (20.4%) | 6/75 (8%) | 3/75 (4%) | |||
| Rash | 9/49 (18.4%) | 21/75 (28%) | 5/75 (6.7%) | |||
| Rash maculo-papular | 6/49 (12.2%) | 9/75 (12%) | 1/75 (1.3%) | |||
| Palmar-plantar erythrodysaethesia syndrome | 2/49 (4.1%) | 5/75 (6.7%) | 11/75 (14.7%) | |||
| Vascular disorders | ||||||
| Hypotension | 3/49 (6.1%) | 4/75 (5.3%) | 3/75 (4%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The sponsor can review results communications prior to public release and embargo communications of results up to 60 days.
Results Point of Contact
| Name/Title | Tegan Nguyen |
|---|---|
| Organization | Sumitomo Dainippon Pharma Oncology |
| Phone | 617-674-8745 |
| tnguyen@bostonbiomedical.com |
Responsible Party:
Sumitomo Pharma Oncology, Inc.
ClinicalTrials.gov Identifier:
NCT01776307
Other Study ID Numbers:
- BBI608-224
First Posted:
Jan 28, 2013
Last Update Posted:
Apr 6, 2022
Last Verified:
Apr 1, 2022